Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega

• Conditions: Obesity; Bypass Complication
• Interventions: Other: Ten year evaluation

• Registration Number: NCT04930029
• Lead Sponsor: University Hospital, Lille

Brief Summary

The omega gastric bypass (OAGB) is developing worldwide as an alternative to the Y gastric bypass (RYGB). Cases of nutrition deficiency after OAGB, in particular protein deficency, are regularly reported in the literature, raising the question of the medium/long-term safety of this procedure. In its technology assessment report issued in September 2019 (HAS, 2019), the Haute Autorité de Santé rules on the invalidity of OAGB with a 200 cm biliary limb and the lack of sufficient data on the safety of OAGB with a 150 cm biliary limb compared to RYGB. The lack of long-term data on weight, resolution of comorbidities, quality of life, and endoscopic evaluation given the risk of lower esophageal cancer is also noted.

The main objective of the study is to compare the incidence of serious adverse events related to surgery after OAGB at 10 years, according to 2 types of loop: a realization with a 150-cm biliary loop (OAGB AB150) versus a realization with a 200-cm biliary loop (OAGB AB200).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15
• Study Start: 2022-09
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Patients who received 10 ± 2 years ago (between 2009 and 2013) an OAGB with a 150 or 200cm biliary limb. Patients should be consecutive at each center.
• Patients fulfilling the criteria of indication for bariatric surgery at the time of their intervention according to the recommendations of the HAS (HAS, 2009) in an expert center.
• Patients agreeing to perform an endoscopic evaluation with biopsies at 10 years
• Patients who gave their consent
• Patients with health insurance coverage

Exclusion Criteria

• Contraindication to bariatric surgery defined according to HAS recommendations (HAS, 2009)
• Persons deprived of liberty, under guardianship, or under curatorship
• Patients included in a protocol with a conflict of interest with OMEGA10.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OAGB200	Ten year evaluation	One anastomosis gastric bypass with 200cm biliary limb
OAGB150	Ten year evaluation	One anastomosis gastric bypass with 150cm biliary limb

Primary Outcome Measures

Name	Time	Method
Incidence of serious surgery-related adverse events	10 years after surgery	A serious adverse event is defined as a medical event that requires hospitalization, is life-threatening, results in persistent or substantial disability, or results in death. The "surgery-related" character will be described by each investigator in the first instance and homogenized by the group of experts designated at the beginning of the study.

Secondary Outcome Measures

Name	Time	Method
Nutritional clinical status, assessed by dietitian evaluation	10 years after surgery
Obstructive sleep apnea remission	10 years after surgery
GERD	10 years after surgery	GERD, assessed by clinical evaluation, PPI use, and endoscopic signs of GERD (gastritis, oesophagitis, anastomotic ulcer, Barrett's esophagus, gastric metaplasia, esophageal metaplasia
Nutritional biological status , assessed by evaluation of malnutrition parameters	10 years after surgery
Diabetes remission	10 years after surgery
Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires	10 years after surgery	The GIQLI is a score to evaluate digestive disorders in 36 items, ranging from 0 (the worst quality of life) to 144 (the best quality of life).
Excess weight loss percentage	10 years after surgery	calculated as follows: (weight at 10 years - initial weight) / (initial weight - ideal weight) x 100 The ideal weight is defined as the weight corresponding to a BMI = 25 kg/m2. The initial weight is the weight on the day of surgery.
Metabolic comorbidities remission	10 years after surgery
Hypertension remission	10 years after surgery
Dyslipidemia remission	10 years after surgery
incidence of serious adverse events not related to surgery	10 years after surgery
Quality of life by BAROS score (Bariatric analysis and reporting outcome system)	10 years after surgery